Apparatus for improved breathing

ABSTRACT

According to one embodiment, an apparatus for improved breathing is provided. The apparatus may include an improved oral appliance, an improved mask, an improved coupler to couple an oral appliance to a mask, and/or a combination of these improvements.

RELATED APPLICATIONS AND CLAIM TO PRIORITY

This application is a continuation of U.S. Ser. No. 14/009,821, filedNov. 1, 2013, which is a U.S. National Stage Filing under 35 U.S.C. §371 of International Patent Application Serial No. PCT/US2012/032407,filed Apr. 5, 2012 and entitled “Apparatus for Improved Breathing,”which is a continuation of U.S. application Ser. No. 13/080,167, filedApr. 5, 2011 and entitled “Universal Oral Appliance with a UniversalCoupler,” U.S. application Ser. No. 13/080,050, filed Apr. 5, 2011 andentitled “Custom Dental Appliance and Method of Creating a Custom DentalAppliance,” and U.S. application Ser. No. 13/080,103, filed Apr. 5, 2011and entitled “Apparatus for Prevention of Snoring and ImprovedBreathing.” This application claims priority to each ofPCT/US2012/032407 and U.S. application Ser. Nos. 14/009,821, 13/080,167,13/080,050, and 13/080,103.

TECHNICAL FIELD OF THE INVENTION

This invention relates generally to medical and dental devices; and moreparticularly to an apparatus for improving a user's breathing.

BACKGROUND

Many people experience difficulty in sleeping because of breathingproblems. These problems may result in snoring, or the more seriouscondition of sleep apnea. One treatment for sleep breathing disordersinvolves the use of dental devices for extending forward the lower jawof the patient. These devices operate to more fully open the breathingpassageway, thereby allowing for easier breathing, whether thatbreathing be through the nose or through the mouth. Furthermore, manypeople suffer from degraded teeth or jaw pain arising from bruxing orthe grinding of teeth during sleep. One treatment for grinding involvesthe use of dental devices that put pressure on a patient's front teethto relax and unclench the patient's jaw.

These dental devices may be created in labs after a dentist sends in apatient's dental impressions. This procedure can cost the patientsubstantial time and money because the dentist creates a dentalimpression and then the lab creates the dental device after the dentistsends in the dental impression. Also, these lab-created dental devicesare often designed to target particular problems. For example, a devicefor treating snoring may not help a patient who grinds his teeth.

People who suffer from sleep problems may seek help from a sleeplaboratory. Doctors at the laboratory may perform tests on patients asthey sleep. Doctors may further test the effectiveness of various dentaldevices on the patients as treatment options. During tests, doctors mayneed quick access inside a patient's mouth, and dental devices that hookor attach inside the patient's mouth may hinder the doctors' ability togain quick access inside the mouth. This scenario may also occur duringsurgery when a patient is unconscious, and a dental device is insertedinto the mouth to maintain the patient's airway.

Another treatment for sleep breathing disorders involves the use ofmasks to deliver air to users. These masks may also be used to deliveroxygen or other gases to a user. One difficulty with these masks is thatthey often move while the user is sleeping or they are uncomfortable tothe user when worn.

SUMMARY OF THE INVENTION

In accordance with the teachings of the present invention, a dentaldevice is provided which may reduce or eliminate disadvantages andproblems associated with prior art devices.

In one embodiment, a dental device is provided comprising an archedframe and a moldable tray. The arched frame may be configured to bepositioned proximate to the occlusal surface of a user's dental archsuch that the arched frame extends beyond the cuspids of the user'sdental arch. The arched frame may define a plurality of apertures andmay comprise an adjustment mechanism. The moldable tray may be coupledto the arched frame and may engage the plurality of apertures. Themoldable tray may comprise a channel configured to engage at least someof the teeth of the user's dental arch.

In a particular embodiment, a dental device is provided comprising anarched frame, a moldable tray, a second arched frame, and a secondmoldable tray. The arched frame may be configured to be positionedproximate to the occlusal surface of a user's maxillary arch such thatthe arched frame extends beyond the cuspids of the user's maxillaryarch. The arched frame may define a plurality of apertures and maycomprise an adjustment mechanism. The adjustment mechanism may comprisea hook and a threaded adjustor. The moldable tray may be coupled to thearched frame and may engage the plurality of apertures. The moldabletray may comprise a channel configured to engage at least some of theteeth of the user's maxillary arch. The second arched frame may beconfigured to be positioned proximate to the occlusal surface of auser's mandibular arch such that the second arched frame extends beyondthe cuspids of the user's mandibular arch. The second arched frame maydefine a second plurality of apertures and may comprise a receivingmechanism coupled to the lingual portion of the lower arched body. Thesecond moldable tray may be coupled to the second arched frame and mayengage the plurality of apertures. The second moldable tray may comprisea second channel configured to engage at least some of the teeth of theuser's mandibular arch. The hook may engage the receiving mechanism, andthe threaded adjustor may adjust the forward position of the archedframe relative to the second arched frame.

In another embodiment, a dental device may include an arched frameconfigured to be positioned proximate to the occlusal surface of auser's dental arch such that the arched frame extends beyond the cuspidsof the user's dental arch. The arched frame may define a plurality ofapertures. The dental device may further include an adjustment mechanismcoupled to the arched frame. The dental device may further include amoldable tray coupled to the arched frame. The moldable tray may engagethe plurality of apertures and may comprise a channel configured toengage at least some of the teeth of the user's dental arch.

In another embodiment, a dental device may include an arched frameconfigured to be positioned proximate to the occlusal surface of auser's maxillary arch such that the arched frame extends beyond thecuspids of the user's maxillary arch. The arched frame may define aplurality of apertures. The dental device may further include anadjustment mechanism coupled to the arched frame. The adjustmentmechanism may comprise a hook and a threaded adjustor. The dental devicemay further include a moldable tray coupled to the arched frame. Themoldable tray may engage the plurality of apertures and may comprise achannel configured to engage at least some of the teeth of the user'smaxillary arch. The dental device may further include a second archedframe configured to be positioned proximate to the occlusal surface of auser's mandibular arch such that the arched frame extends beyond thecuspids of the user's mandibular arch. The second arched frame maydefine a second plurality of apertures. The dental device may furtherinclude a receiving mechanism coupled to the lingual portion of thesecond arched frame and a second moldable tray coupled to the secondarched frame. The second moldable tray may engage the second pluralityof apertures and may comprise a second channel configured to engage atleast some of the teeth of the user's mandibular arch. The hook mayengage the receiving mechanism and the threaded adjustor may adjust theforward position of the arched frame relative to the second archedframe.

In another embodiment, a universal oral appliance is provided comprisingan arched frame. The arched frame may be configured to be positionedproximate to the occlusal surface of a user's dental arch such that thearched frame extends beyond the cuspids of the user's dental arch whenthe universal oral appliance is inserted in the user's mouth. The archedframe may have a midline that aligns substantially with the anteriormidline of the user's mouth when the universal oral appliance isinserted in the user's mouth. The arched frame may define a plurality ofapertures and may comprise a universal coupler configured to removablyengage a dental attachment. The universal coupler may comprise asubstantially planar surface proximate to and extending across themidline of the arched frame. The universal coupler may be configured tobe positioned proximate to the occlusal surface of a user's incisorswhen the universal oral appliance is inserted in the user's mouth. Theuniversal coupler may further comprise a first rail coupled to a firstend of the substantially planar surface and a second rail coupled to asecond end of the substantially planar surface. The first rail, secondrail, and substantially planar surface may define a slot.

In another embodiment, a kit for use in constructing a universal oralappliance is provided. The kit may comprise an arched frame and aplurality of dental attachments. The arched frame may be configured tobe positioned proximate to the occlusal surface of a user's dental archsuch that the arched frame extends beyond the cuspids of the user'sdental arch when the universal oral appliance is inserted in the user'smouth. The arched frame may have a midline that aligns substantiallywith the anterior midline of the user's mouth when the universal oralappliance is inserted in the user's mouth. The arched frame may define aplurality of apertures and may comprise a universal coupler. Theuniversal coupler may comprise a substantially planar surface proximateto and extending across the midline of the arched frame. Thesubstantially planar surface may be configured to be positionedproximate to the occlusal surface of a user's incisors when theuniversal oral appliance is inserted in the user's mouth. The universalcoupler may further comprise a first rail coupled to a first end of thesubstantially planar surface and a second rail coupled to a second endof the substantially planar surface. The first rail, second rail, andsubstantially planar surface may define a slot. The kit may furthercomprise a plurality of dental attachments comprising a roundedprojection configured to be the point of contact between the user'supper and lower dental arches to prevent the user from clenching hisjaw. The plurality of dental attachments may further comprise a hookconfigured to engage a receiving mechanism such that the forwardposition of a second arched frame may be adjusted relative to theposition of the arched frame.

In another embodiment, a universal oral appliance is provided comprisingan arched frame, a moldable tray, and a plurality of dental attachments.The arched frame may be configured to be positioned proximate to theocclusal surface of a user's dental arch such that the arched frameextends beyond the cuspids of the user's dental arch when the universaloral appliance is inserted in the user's mouth. The arched frame mayhave a midline that aligns substantially with the anterior midline ofthe user's mouth when the universal oral appliance is inserted in theuser's mouth. The arched frame may define a plurality of apertures andmay comprise a universal coupler. The universal coupler may comprise asubstantially planar surface proximate to and extending across themidline of the arched frame. The substantially planar surface may beconfigured to be positioned proximate to the occlusal surface of auser's incisors when the universal oral appliance is inserted in theuser's mouth. The universal coupler may further comprise a first railcoupled to a first end of the substantially planar surface and a secondrail coupled to a second end of the substantially planar surface. Thefirst rail, second rail, and substantially planar surface may define aslot. The moldable tray may be coupled to the arched frame and maycomprise a channel configured to engage at least some of the teeth ofthe user's dental arch. The dental attachment may include asubstantially rounded projection configured to be the point of contactbetween the user's upper and lower dental arches to prevent the userfrom clenching his jaw. The dental attachment may be an adjustable hookconfigured to engage the receiving mechanism such that the forwardposition of the arched frame is adjustable relative to the position of asecond arched frame. The dental attachment may be a handle.

In another embodiment, a dental device is provided comprising an arch, adental attachment with an anchoring element, a second arch with a secondanchoring element, and a tension element. The arch may be configured toengage at least some of the teeth of a user's dental arch and may have amidline that aligns substantially with the anterior midline of theuser's mouth when the arch is inserted in the user's mouth. The dentalattachment may be configured to engage the arch along the midline of thearch. The dental attachment may comprise an anchoring element configuredto be outside the user's mouth when the arch is inserted in the user'smouth. The second arch may be configured to engage at least some of theteeth of a user's second dental arch. The second arch may have a midlinethat aligns substantially with the anterior midline of the user's mouthwhen the second arch is inserted in the user's mouth. The secondanchoring element may be coupled to the second arch along the midline ofthe second arch. The tension element may be configured to engage thesecond anchoring element. The tension element may be further configuredto couple to the anchoring element outside the user's mouth when thearch is inserted in the user's mouth.

In another embodiment, a kit for constructing a dental device isprovided. The kit may comprise an arch, a dental attachment with ananchoring element, a second arch with a second anchoring element, and atension element. The arch may be configured to engage at least some ofthe teeth of a user's dental arch and may have a midline that alignssubstantially with the anterior midline of the user's mouth when thearch is inserted in the user's mouth. The dental attachment may beconfigured to engage the arch along the midline of the arch. The dentalattachment may comprise an anchoring element configured to be outsidethe user's mouth when the arch is inserted in the user's mouth. Thesecond arch may be configured to engage at least some of the teeth of auser's second dental arch. The second arch may have a midline thataligns substantially with the anterior midline of the user's mouth whenthe second arch is inserted in the user's mouth. The second anchoringelement may be coupled to the second arch along the midline of thesecond arch. The tension element may be configured to engage the secondanchoring element. The tension element may be further configured tocouple to the anchoring element outside the user's mouth when the secondarch is inserted in the user's mouth.

In another embodiment, a dental device is provided comprising an archedframe, a moldable tray, a dental attachment with an anchoring element, asecond arched frame with a second anchoring element, a second moldabletray, and a tension element. The arched frame may be configured to bepositioned proximate to the occlusal surface of a user's maxillary archsuch that the arched frame extends beyond the cuspids of the user'smaxillary arch. The arched frame may define a plurality of apertures.The moldable tray may be coupled to the arched frame and may engage theplurality of apertures. The moldable tray may comprise a channelconfigured to engage at least some of the teeth of the user's maxillaryarch. The dental attachment may be configured to removably engage thearch along the midline of the arch. The dental attachment may comprisean anchoring element configured to be outside the user's mouth when thearch is inserted in the user's mouth. The second arched frame may beconfigured to be positioned proximate to the occlusal surface of auser's mandibular arch such that the second arched frame extends beyondthe cuspids of the user's mandibular arch. The second arched frame maydefine a second plurality of apertures. The second moldable tray may becoupled to the second arched frame and may engage the second pluralityof apertures. The second moldable tray may comprise a channel configuredto engage at least some of the teeth of the user's mandibular arch. Thesecond anchoring element may be coupled to the second arch along themidline of the second arch. The tension element may be configured toremovably engage the second anchoring element. The tension element maybe configured to couple to the anchoring element outside the user'smouth when the second arch is inserted in the user's mouth. The dentalattachment may comprise a post and a buckle coupled to a first end ofthe post. A second end of the post may engage the arch. The tensionelement may comprise a coupler and a strap coupled to the coupler. Thecoupler may engage the second anchoring element. A length of the strapmay be configured to engage the buckle. The buckle may be configured tosubstantially secure the length of the strap engaging it. By increasingthe length of the strap engaging the buckle, the forward position of thearched frame relative to the second arched frame may be adjusted.

In another embodiment, a coupler includes a support structure, at leastone flange, and an elongated fastener. The support structure includes afirst channel and a slot passing through the first channel and beingsubstantially orthogonal to the first channel. The flange is partiallywithin the first channel and the flange has a slot disposed through theflange. The elongated fastener is disposed within the slot of thesupport structure and passes through the slot of the flange to engagethe flange, such that the flange is adjustably positioned within thefirst channel. The coupler is attached to an oral appliance having anocclusal surface and to a mask configured to deliver gas to a user, suchthat the orientation of the mask to the oral appliance is adjustable byrotating the flange about the fastener and adjustable in a directionsubstantially orthogonal to the occlusal surface of the oral appliance.

In another embodiment, an apparatus for use in forming a dental deviceincludes a substantially rigid arched frame configured to be positionedproximate to the occlusal surface of a user's dental arch, such that thearched frame extends beyond the cuspids of the user's dental arch. Thearched frame includes a first occlusal surface, a second occlusalsurface, and a flange. The first occlusal surface is configured to bepositioned proximate to the occlusal surface of the user's left molars.The second occlusal surface is configured to be positioned proximate tothe occlusal surface of the user's right molars. The second occlusalsurface is separated from the first occlusal surface. The flangeconnects the first and second occlusal surfaces, the flange extends in adirection substantially orthogonal to the first and second occlusalsurfaces, and the flange is configured to be positioned labial to theuser's dental arch.

In another embodiment, a dental device includes a substantially rigidarched frame and a thermoplastic material. The substantially rigidarched frame is configured to be positioned proximate to the occlusalsurface of a user's dental arch, such that the arched frame extendsbeyond the cuspids of the user's dental arch. The arched frame includesan occlusal surface configured to be positioned proximate to theocclusal surface of the user's dentition. The thermoplastic materialencloses at least a portion of the arched frame, such that occlusalsurface of the arched frame is substantially enclosed by thethermoplastic material.

In another embodiment, an improved breathing device includes a mask, anoral appliance, and a tension element. The mask includes an openingconfigured to be positioned in front of the user's mouth when the maskis positioned on the user's face. The mask further includes a couplingelement proximate to the opening. The oral appliance includes amaxillary arch with an anchor point proximate to the midline of themaxillary arch. The tension element is configured to couple to the adental device at the anchor point and to couple to the mask at thecoupling element. In certain embodiments, the tension element may beadjusted to pull the mask towards the oral appliance. In a particularembodiment, the coupling element is a strap that extends across aportion of the opening and includes one or more apertures through whichthe tension element may extend, the tension element includes a hook anda threaded knob, and the anchor point includes a loop, such that themask is pulled toward the oral appliance as the threaded knob is turnedwhile hook is coupled to the loop and extends through an aperture in thestrap.

Previous dental devices may be constructed in labs independent of adentist's office. Labs could not construct custom dental devices forparticular patients without first having the patients' dentalimpressions. Labs may also charge patients an extra fee for constructingthe dental devices. In particular embodiments, the dental device may beconstructed at the dentist's office without sending dental impressionsto a lab, thus saving patients time and money. Furthermore, previousdental devices may be created to treat only one disorder (such as, forexample, snoring or jaw-clenching). In particular embodiments, thedental device may be customized to treat multiple dental problems. As anexample, and not by way of limitation, the dental device may comprise auniversal coupler configured to engage various dental attachments. Eachdental attachment may be designed to treat a different disorder.Additionally, previous dental devices may limit the lower jaw's range ofmotion when the dental devices were inserted in the user's mouth.Previous dental devices may also limit a third party's access to theuser's mouth when the dental device is in the user's mouth. Inparticular embodiments, the dental device may comprise a tension elementengaging an anchoring element outside the user's mouth. The tensionelement and anchoring element may pull the user's lower jaw forwardwithout locking the user's lower jaw in place. Furthermore, a thirdparty may pull on the tension element to open the user's airway, or athird party may release the tension element from the anchoring elementto quickly gain access to a user's mouth. Certain embodiments mayprovide all, some, or none of these advantages. Certain embodiments mayprovide one or more other advantages, one or more of which may beapparent to those skilled in the art from the figures, descriptions, andclaims included herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example arched frame.

FIG. 2A illustrates an example arched frame comprising an adjustmentmechanism.

FIG. 2B illustrates an example arched frame comprising a receivingmechanism.

FIG. 2C illustrates an example arched frame comprising a receivingmechanism.

FIG. 3A illustrates an example arched frame comprising an adjustmentmechanism, and an example moldable tray.

FIG. 3B illustrates an example arched frame comprising a receivingmechanism, and an example moldable tray.

FIG. 3C illustrates an example arched frame comprising an adjustmentmechanism, and an example moldable tray.

FIG. 3D illustrates an example arched frame comprising a receivingmechanism, and an example moldable tray.

FIG. 4 illustrates an example dental device in a user's mouth.

FIG. 5A illustrates an example universal oral appliance comprising auniversal coupler.

FIG. 5B illustrates an example universal oral appliance comprising auniversal coupler.

FIG. 5C illustrates an example universal oral appliance comprising auniversal coupler.

FIG. 5D illustrates an example universal oral appliance comprising auniversal coupler comprising a guided channel.

FIG. 5E illustrates an example universal oral appliance comprising auniversal coupler comprising a raised surface.

FIG. 6 illustrates an example universal oral appliance comprising auniversal coupler, and an example plurality of dental attachments.

FIG. 7 illustrates an example dental device in a user's mouth.

FIGS. 8A through 8E illustrate an example arched frame.

FIGS. 9A through 9D illustrate an example moldable tray.

FIGS. 10A through 10C illustrate an example arched frame disposed withinan example moldable tray.

FIGS. 11A and 11B illustrate an example moldable tray and an examplepost.

FIG. 12 illustrates example moldable trays, an example post, and anexample mask.

FIG. 13 illustrates example moldable trays, an example post, and anexample mask.

FIG. 14A illustrates an example post.

FIG. 14B illustrates an example arched frame and tension element.

FIGS. 15A and 15B illustrate example flanges.

FIGS. 16A and 16B illustrate an example post.

FIGS. 17A through 17F illustrate example flanges engaged with an examplepost.

FIG. 18 illustrates an example post.

FIGS. 19A and 19B illustrate an example mask.

FIG. 20 illustrates an example mask, post, and oral appliance.

FIG. 21A illustrates an example mask and post.

FIG. 21B illustrates an example mask, post, and oral appliance.

FIG. 22A illustrates an example mask including a strap.

FIG. 22B illustrates an example tension element, oral appliance, andmask.

FIGS. 23A and 23B illustrate an example mask comprising a strap.

FIG. 24 illustrates an example tension element, oral appliance, andmask.

FIGS. 25A and 25B illustrate an example mask and adapter.

FIGS. 26A and 26B illustrate an example adapter.

FIG. 27 illustrates an example dental device comprising a universalcoupler and an example dental attachment.

FIG. 28 illustrates an example dental device comprising a universalcoupler and an example dental attachment.

FIG. 29 illustrates an example arch comprising a dental attachment.

FIG. 30 illustrates an example arch comprising a tension element.

FIG. 31 illustrates an example dental device comprising a dentalattachment and a tension element.

FIG. 32 illustrates an example dental attachment and tension element.

FIG. 33 illustrates an example dental device in a user's mouth.

FIG. 34 illustrates an example process for creating a dental device.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates an example arched frame 100. Arched frame 100 maycomprise an arched body 105 that defines a plurality of apertures 110through arched frame 100. In particular embodiments, arched frame 100may be configured to be positioned proximate to the occlusal surface ofa user's dental arch. In some embodiments, arched frame 100 may extendbeyond the cuspids of the user's dental arch when arched frame 100 isinserted in the user's mouth. In some embodiments, arched frame 100 mayhave a consistent thickness between 1.5 and 2 millimeters. FIG. 2Aillustrates an example arched frame comprising an adjustment mechanism.As shown in FIG. 2A, an arched frame 100 is provided comprising anarched body 105 defining a plurality of apertures 110 and an adjustmentmechanism 115. In particular embodiments, arched body 105 may define aplurality of grooves, or a slot. Adjustment mechanism 115 may be coupledto arched body 105 along the midline of arched frame 100. In certainembodiments, Adjustment mechanism 115 may comprise a hook 120 and athreaded adjustor 125. FIGS. 2B and 2C illustrate arched frames eachcomprising a receiving mechanism. As shown in FIGS. 2B and 2C, an archedframe 100 is provided comprising an arched body 105 defining a pluralityof apertures 110 and a receiving mechanism 130. In particularembodiments, receiving mechanism 130 may be a bar spanning a portion ofthe arch of arched body 105. In other embodiments, receiving mechanism130 may be a surface coupled to the lingual portion of arched frame 100.In some embodiments, the surface may be rounded.

In particular embodiments, arched frame 100 may be formed from anymaterial suitable for dental uses, for example, a hard plastic. Archedframe 100 may be formed from methyl methacrylate or a polycarbonateresin thermoplastic such as that sold under the Registered TrademarkLexan. Such materials are known to those familiar with dental devices,and other suitable materials may be used to form arched frame 100without departing from the intended scope of the present invention.

FIGS. 3A and 3C illustrate example arched frames each comprising anadjustment mechanism and example moldable trays. As shown in FIGS. 3Aand 3C, an arched frame 100 and a moldable tray 135 are provided. Archedframe 100 may comprise an arched body 105 defining a plurality ofapertures 110 and an adjustment mechanism 115. Moldable tray 135 may becoupled to arched frame 100 and may engage the plurality of apertures110. In particular embodiments, moldable tray 135 may form throughplurality of apertures 110 to couple to two sides of arched body 105. Insome embodiments, moldable tray 135 may form into a plurality of groovesdefined by arched body 105. In some embodiments, moldable tray 135 maybe secured to arched frame 100 by forming through a slot defined byarched body 105. Moldable tray 135 may further comprise a channel 140that is configured to engage at least some of a user's dental arch. Inparticular embodiments, channel 140 may engage the incisors and cuspidsof the user's dental arch. In some embodiments, channel 140 may engagethe incisors, cuspids, and some of the molars of the user's dental arch.In some embodiments, channel 140 may engage the incisors, cuspids, andall the molars of the user's dental arch. In particular embodiments,channel 140 may be shaped to conform to a generic user's teeth. In otherembodiments, channel 140 may be a smooth channel that covers a user'steeth. In particular embodiments, channel 140 may be further shaped toconform to a particular user's teeth.

In particular embodiments, moldable tray 135 may comprise apolycaprolactone polymer or other aliphatic polyester. One or more ofthe polycaprolactone polymers may have the formula:

where R is an aliphatic hydrocarbon and n may range from approximately300 to approximately 650. Certain embodiments may utilizepolycaprolactone polymers using other suitable formulas. One particularembodiment may utilize Nylon.

Moldable tray 135 may include any suitable polycaprolactone polymer orother aliphatic polyester, for example, and not by way of limitation,the TONE P 700, TONE P 767, or TONE P 787 polycaprolactone polymersmanufactured by Union Carbide Corporation, taken singly or in anycombination. A suitable light cured material, another polymer, or anyother suitable material, such as a filler, coloring agent, stabilizer,antioxidant, or antimicrobial agent, may be used to replace or combinewith one or more of the polycaprolactone polymers in forming adeformable material 20 having any number of characteristics, properties,or uses.

The TONE polycaprolactone polymers are described in U.S. Pat. Nos.5,112,225 and 4,784,123, and in literature distributed by Union CarbideCorporation, as homopolymers, block copolymers, graft copolymers, orother polymers that contain epsilon caprolactone. Polymerization may beinitiated using one or more diols, for example, and not by way oflimitation, ethylene glycol; diethylene glycol; neopentyl glycol; butanediol; hexane diol; or any other suitable diol.

In particular embodiments, moldable tray 135 may be custom molded to auser's teeth. For example, moldable tray 135 may comprise a materialthat is moldable when heated. Once heated, the material may be pressedaround a user's dental arch to form a moldable tray 135 that conforms tothe user's teeth. In particular embodiments, moldable tray 135 may beused with arched frame 100 to form a custom dental device. For example,arched frame 100 may comprise a hard plastic material. When moldabletray 135 is forming around a user's teeth, arched frame 100 may bepressed against moldable tray 135, so that mold tray 135 forms throughplurality of apertures 110 defined by arched body 105. As moldable tray135 cools and hardens, moldable tray 135 may couple to arched frame 100through plurality of apertures 110. In some embodiments, moldable tray135 may couple to arched frame 100 through a slot or by forming into aplurality of grooves. In particular embodiments, arched frame 100 mayprovide structural support for moldable tray 135 as moldable tray 135engages the user's teeth. For example, as moldable tray 135 engages theuser's teeth, arched frame 100 may prevent moldable tray 135 fromdeforming or shifting under the stresses caused by movement of theuser's mouth.

In particular embodiments, a custom dental device may comprise archedframe 100 and moldable tray 135. A dentist may be able to construct thecustom dental device for a patient without having to send the patient'sdental impressions to a lab. The dentist may heat moldable tray 135 andpress moldable tray 135 around the user's teeth. The dentist may thenpress arched frame 100 against moldable tray 135 to construct the customdental device. As a result, the patient may not have to wait for the labto create the dental device, nor does the patient have to pay an extrafee charged by the lab.

FIGS. 3B and 3D illustrate example arched frames each comprising areceiving mechanism, and example moldable trays. As shown in FIGS. 3Band 3D, an arched frame 100 and a moldable tray 135 are provided. Archedframe 100 may comprise an arched body 105 defining a plurality ofapertures 110 and a receiving mechanism 130. Receiving mechanism 130 maybe coupled to arched body 105. In particular embodiments, receivingmechanism 130 may be a bar that spans a portion of the arch of archedbody 105. Moldable tray 135 may comprise a channel 140 that isconfigured to engage at least some of the teeth of a user's dental arch.

FIG. 4 illustrates an example dental device in a user's mouth. As shownin FIG. 4, a dental device is provided that comprises an arched frame100, a moldable tray 135, a second arched frame 200, and a secondmoldable tray 235. Arched frame 100 may comprise an adjustment mechanism115 that comprises a hook 120 and a threaded adjustor 125. Moldable tray135 may be coupled to arched frame 100. Moldable tray 100 may comprise achannel 140. In some embodiments, channel 140 may be shaped to conformto a generic user's maxillary arch 305. In other embodiments, channel140 may be a smooth channel that covers some of teeth of a user'smaxillary arch 305. In particular embodiments, channel 140 may befurther shaped to conform to a particular user's maxillary arch 305.Second arched frame 200 may comprise a second arched body 205 defining asecond plurality of apertures 210. Second arched frame 200 may furthercomprise a receiving mechanism 130 coupled to the lingual portion ofsecond arched body 205. In some embodiments, receiving mechanism 130 maybe a bar that spans a portion of the arch of second arched body 205.Second moldable tray 235 may be coupled to second arched frame 200 andmay engage second plurality of apertures 210. Second moldable tray 235may be configured to engage some of the teeth of the user's mandibulararch 300. In particular embodiments, hook 120 may engage receivingmechanism 130. Threaded adjustor 125 may be used to adjust the forwardposition of arched frame 100 relative to second arched frame 200. Therelative positions of the two arched frames 100 and 200 may adjust theposition of the user's maxillary arch 305 relative to the user'smandibular arch 300. In some embodiments, the relative position of theuser's maxillary and mandibular arches may help to improve a user'sbreathing and/or prevent the user from snoring while sleeping.

FIGS. 5A and 5B each illustrate an example universal oral appliancecomprising a universal coupler. As shown in FIGS. 5A and 5B, a universaloral appliance is provided comprising an arched frame 100 and a moldabletray 135 coupled to arched frame 100. Arched frame 100 may comprise anarched body 105 defining a plurality of apertures 110. In particularembodiments, arched frame 100 may be configured to be positionedproximate to the occlusal surface of a user's dental arch such thatarched frame 100 extends beyond the cuspids of the user's dental archwhen arched frame 100 is inserted in the user's mouth. Arched frame 100may have a midline that aligns substantially with the anterior midlineof the user's mouth when arched frame 100 is inserted in the user'smouth. Arched frame 100 may further comprise a universal coupler. Inparticular embodiments, the universal coupler may comprise asubstantially planar surface 145, a first rail 146, and a second rail147. Substantially planar surface 145 may be proximate to and extendacross the midline of arched frame 100. In particular embodiments,substantially planar surface 145 may be configured to be positionedproximate to the occlusal surface of a user's incisors when theuniversal oral appliance is inserted in the user's mouth. First rail 146may be coupled to a first end of substantially planar surface 145. Inparticular embodiments, first rail 146 may be distal to the midline ofarched frame 100. In other embodiments, first rail 146 may be anteriorto arched frame 100. Second rail 147 may be coupled to a second end ofsubstantially planar surface 145. In particular embodiments, second rail147 may be distal to the midline of arched frame 100. In otherembodiments, second rail 147 may be posterior to arched frame 100. Firstrail 146 and second rail 147 may form an acute angle with substantiallyplanar surface 145. In particular embodiments, first rail 146, secondrail 147, and substantially planar surface 145 may define a slot. Inparticular embodiments, a dental attachment may slide into the slot andengage arched frame 100. In some embodiments, the universal coupler maycomprise a locking mechanism (such as, for example, a screw, a tab, or agroove). The screw may secure a dental attachment to the universalcoupler by screwing through the dental attachment and into the universalcoupler. The tab may secure the dental attachment by engaging theexterior of the dental attachment or by engaging a slot in the dentalattachment. The groove may secure the dental attachment by frictionallyengaging the dental attachment. In particular embodiments, the universalcoupler may further comprise a stop 148 coupled to substantially planarsurface 145. Stop 148 may be coupled to the labial or lingual ends ofsubstantially planar surface 145. Alternatively, stop 148 may be coupledto a distal end of substantially planar surface 145. Although thisdisclosure describes a universal oral appliance comprising arched frame100, moldable tray 135, and a universal coupler coupled to arched frame100, this disclosure contemplates a one-piece universal oral applianceand a universal coupler coupled to the universal oral appliance.

FIG. 5C illustrates an example universal oral appliance comprising auniversal coupler. As shown in FIG. 5C, a universal oral appliance isprovided comprising an arched frame 100 and a moldable tray 135 coupledto arched frame 100. Arched frame 100 may comprise a universal couplercomprising a substantially planar surface 145, a first rail 146, asecond rail 147, and a stop 148. In particular embodiments, each rail146 and 147 may comprise a first segment 149 and a second segment 150.First segment 149 may be coupled at a first end to substantially planarsurface 145, and second segment 150 may be coupled to a second end offirst segment 149. In particular embodiments, first segment 149 andsecond segment 150 may be substantially perpendicular to each other.

FIG. 5D illustrates an example universal oral appliance comprising auniversal coupler comprising a guided channel. As shown in FIG. 5D, auniversal oral appliance is provided comprising an arched frame 100 anda moldable tray 135. Arched frame 100 may comprise a universal couplercomprising a substantially planar surface 145, a first rail 146, asecond rail 147, and a stop 148. First rail 146, second rail 147, andsubstantially planar surface 145 may define a slot. In particularembodiments, the universal coupler may further comprise a guided channel151. Guided channel 151 may be configured to guide a dental attachmentthrough the slot.

FIG. 5E illustrates an example universal oral appliance comprising auniversal coupler comprising a raised surface 152. As shown in FIG. 5E,a universal oral appliance is provided comprising an arched frame 100and a moldable tray 135. Arched frame 100 may comprise a universalcoupler comprising a substantially planar surface 145, a first rail 146,a second rail 147, and a stop 148. First rail 146, second rail 147, andsubstantially planar surface 145 may define a slot. In particularembodiments, the universal coupler may further comprise a raised surface152. Raised surface 152 may be configured to guide a dental attachmentthrough the slot. In particular embodiments, raised surface 152 may befurther configured to secure or lock the dental attachment.

FIG. 6 illustrates an example universal oral appliance comprising auniversal coupler, and an example plurality of dental attachments 400.As shown in FIG. 6, an example universal oral appliance is provided thatcomprises an arched frame 100 and a moldable tray 135. Arched frame 100comprises an arched body 105 that defines a plurality of apertures 110.Arched frame 100 further comprises a universal coupler. The universalcoupler may comprise a substantially planar surface 145, a first rail146, a second rail 147, and a stop 148. In particular embodiments, firstrail 146, second rail 147, and substantially planar surface 145 maydefine a slot. FIG. 6 also illustrates a plurality of dental attachments400. In particular embodiments, the plurality of dental attachments 400may comprise dental attachments configured to treat different disorders.For example, the plurality of dental attachments 400 may include a hook405, a substantially rounded projection 415, and an adjustable hook 420.Other attachments may include a handle or any other appropriateattachment configured for use with an oral appliance. A user or amedical professional may choose which dental attachment to use withouthaving to hire a lab to construct a new oral appliance. In someembodiments, dental attachments 400 may be configured to engage theslot.

FIG. 7 illustrates an example dental device in a user's mouth. As shownin FIG. 7, a dental device is provided that comprises an arched frame100, a moldable tray 135 coupled to arched frame 100, a second archedframe 200, and a second moldable tray 235 coupled to arched frame 200.Arched frame 100 may comprise a universal coupler. The universal couplermay comprise a stop 148. Moldable tray 135 may comprise a channel 140that is configured to engage at least some of the teeth of the user'smaxillary arch 305. Second arched frame 200 may comprise a second archedbody 205 that defines a second plurality of apertures 210. Second archedframe 200 may further comprise a receiving mechanism 130 that spans thelingual portion of second arched frame 200. In particular embodiments,receiving mechanism 130 may be a bar. Second moldable tray 235 mayengage second plurality of apertures 210. The dental device furthercomprises a dental attachment that is configured to engage the universalcoupler. In some embodiments, the dental attachment may be an adjustablehook 420 that comprises a hook 120 and a threaded adjustor 125. Hook 120may engage receiving mechanism 130. Threaded adjustor 125 may be used toadjust the forward position of second arched frame 200 relative toarched frame 100. This adjustment may adjust the forward position of theuser's mandibular arch 300 relative to the position of the user'smaxillary arch 305. In some embodiments, this adjustment may help toprevent the user from snoring while sleeping.

FIG. 8A illustrates an example arched frame 700. Arched frame 700 mayinclude an occlusal surface 702 and a flange 706. In particularembodiments arched frame 700 may be configured to be positionedproximate to a user's dental arch, with occlusal surface 702 positionedproximate to the occlusal surface of the user's dental arch. In certainembodiments, occlusal surface 702 may be contiguous throughout thelength of arched frame 700. In alternative embodiments, as shown in FIG.8A, occlusal surface 702 may not be contiguous throughout the length ofarched frame 700. For example, occlusal surface 702 may have a firstportion configured to be positioned proximate to the user's leftbicuspid and first molar; and have a second portion configured to bepositioned proximate to the user's right bicuspid and first molar. Asshown in FIG. 8A, in certain embodiments, occlusal surface 702 may notextend to the area proximate to the user's incisors. Certain embodimentsin which the occlusal surface 702 is not contiguous throughout thelength of arched frame 700 may allow for improved flexibility of archedframe 700. In certain embodiments, arched frame 700 may be capable offlexing inward and/or outward, allowing arched frame 700 to conform to awider variety of dental arch shapes and sizes. Such embodiments may alsoimprove the ability of arched frame 700 to accommodate the overlap ofthe user's maxillary and mandibular incisors, allowing the user's jaw toclose more fully. In certain embodiments, occlusal surface 702 may havea thickness of approximately 1.5 millimeters, although other thicknessesmay be used.

Flange 706 may run along the labial edge of arched frame 700. In certainembodiments, flange 706 may be contiguous throughout the length ofarched frame 700. In alternative embodiments, as shown in FIG. 8A,flange 706 may not be contiguous throughout the length of the archedframe. For example, flange 706 may include a distal flange portion 708and a mesial flange portion 710, separated by a flange recess 712. Incertain embodiments, because flange 706 is positioned proximate to thelabial surface of the user's dental arch, it may be pushed outward bythe labial surface of the user's dental arch when arched frame 700 isinserted into the user's mouth during the molding process, allowingarched frame 700 to automatically flex and align with the user's dentalarch, which may improve the ability of arched frame 700 to accommodatedifferent dental arch sizes and shapes. In certain embodiments, flangerecesses 712 may allow for improved flexibility of arched frame 700. Inaddition, when arched frame 700 is used with deformable material, flangerecesses 712 may allow the deformable material to form an improved moldof the user's teeth. In some embodiments, flange recess 712 may improvethe user's ability to press moldable material against their teeth duringthe molding process, which allow for improved dental molds. In certainembodiments, mesial flange portion 710 may allow for an improved moldwhen arched frame 700 is pressed toward the user's teeth during fitting.As shown in FIG. 8A, in certain embodiments mesial flange portion 710may have a thickness greater than that of distal flange portion 708. Forexample, mesial flange portion 710 may have a thickness of approximately3 millimeters and distal flange portion 708 may have a thickness ofapproximately 1.5 millimeters, although other thicknesses may be used.In such embodiments, the greater thickness of mesial flange portion 710may improve the stability of arched frame 700 during flexion and mayprovide a more secure anchor point for other attached structures, suchas anterior structure 716 shown in FIG. 8B.

FIG. 8B illustrates another example arched frame 700 having occlusalsurface 702, flange 706, and an anterior structure 716. As shown in FIG.8B, in certain embodiments occlusal surface 702 may include an occlusalsurface recess 704. When arched frame 700 is used with deformablematerial, occlusal surface recess 704 may allow the deformable materialto form a closer mold of the user's teeth. As shown in FIG. 8B, certainembodiments may include anterior structure 716 which extends forwardfrom mesial flange portion 710 in an anterior direction. In certainembodiments, anterior structure 716 may be fixed to arched frame 700,while in other embodiments anterior structure 716 may removeably coupledto arched frame 700. FIGS. 8C and 8D illustrate side views of examplearched frames 700 having occlusal surface 702 and flange 706 with distalflange portion 708, flange recess 712, and anterior structure 710.

FIG. 8E illustrates an isometric view of an example arched frame 700. Asshown in FIG. 8E, arched frame 700 may include anterior structure 710,occlusal surface 702 that is not contiguous throughout the length ofarched frame 700, and flange 706 that includes a distal flange portion708, a flange recess 712, a mesial flange portion 710, and a mesialflange recess 714. As shown in FIG. 8E, flange 706 may include mesialflange recess 714 located approximately at the midline of the archedframe. In such embodiments, mesial flange recess 714 may allow forimproved conformity with the shape of the user's mouth. In certainembodiments, the distal ends of arched frame 700 may extendapproximately to the user's first molar when the frame is inserted intothe user's mouth. In alternative embodiments, arched frame 700 mayextend to the user's second molar or to the user's third molar.

FIGS. 9A through 9D illustrate example moldable trays 730. As shown inFIG. 9A, moldable tray 730 may include an occlusal surface 732, an outerrim 734, an inner rim 736, and recesses 738. Occlusal surface 732 may beconfigured to be placed proximate to the occlusal surface of a user'sdental arch. Outer rim 734 may be configured to be positioned proximateto the labial surface of a user's dental arch. In certain embodiments,inner rim 736 may be configured to be positioned proximate to thelingual surface of a user's dental arch. In certain embodiments, innerrim 736 may lie mostly flat relative to the plane of occlusal surface732 or may angle upward slightly. Such embodiments may make moldabletray 730 easier to slide into the user's mouth. In certain embodiments,inner rim 736 may be capable of being pushed upward or downward toengage with the lingual surface of the user's dental arch during themolding process.

As shown in FIG. 9A, in certain embodiments outer rim 734 may have athickness greater than that of inner rim 736. For example, in certainembodiments, outer rim 734 may have a thickness of approximately 3millimeters, while inner rim 736 may have a thickness of approximately 2millimeters, although these dimensions are not required. Reducedthickness of inner rim 736 may allow moldable tray 730 to take up lessspace in the inner mouth area behind the teeth, which may allow the userto breath, swallow, and speak more easily and experience greatercomfort. Reduced thickness of inner rim 736 may also help obviate anyneed to offer multiple sizes of moldable tray 730 and arched frame 700.In certain embodiments, reduced thickness of inner rim 736 may allowother medical and/or dental devices to be more easily inserted into theuser's mouth. In certain embodiments, as shown in FIG. 9D, inner rim 736may be shorter than outer rim 734. A shorter inner rim 736 may allow foreasier insertion of moldable tray 730 into the user's mouth. A shorterinner rim 736 may also reduce the amount of moldable material in theinner mouth area, which may provide additional advantages as describedabove. In certain embodiments, distal portions of moldable tray 730 mayhave a reduced height, which may improve the fit of moldable tray 730 inthe user's mouth.

As shown in FIG. 9A, in certain embodiments occlusal surface 732 mayhave one or more recesses 738, which may result from clamping orotherwise holding in place arched frame 700 during an overmoldingprocess. In certain embodiments, arched frame 700 illustrated in FIGS.8A through 8E may have a corresponding recess, which may allow forimproved clamping and alignment during the manufacturing process.

FIG. 9B shows another example moldable tray 730 having occlusal surface732, outer rim 734, and inner rim 736. As shown in FIG. 9B, in certainembodiments moldable tray 730 may further include an anterior structure740. It should be appreciated that in certain embodiments the optionalanterior structure 740 may be fixed to moldable tray 730 or it may beremoveably coupled to moldable tray 730.

In certain embodiments, moldable tray 730 may be composed of a materialthat can be heated to a temperature at which the material softens andbecomes capable of being molded to a different shape. In certainembodiments, the material can be heated in hot water. In someembodiments, the temperature range at which the material softens may beapproximately 40-80 degrees Celsius, although materials with othersoftening ranges may be used. In a particular embodiment, the targetsoftening temperature may be approximately 60 degrees Celsius. Incertain embodiments, this material may be a thermoplastic. Suchthermoplastic materials may be heated to a temperature at which thethermoplastic becomes soft and moldable, at which point it may be moldedto the shape of at least a portion of a user's dental arch and become atleast temporarily fixed in that shape. As one example, moldable tray 730may comprise a polycaprolactone polymer or other aliphatic polyester, asdiscussed above in reference to moldable tray 135. In particularembodiments, the thermoplastic material may comprise a cross-linkedpolycaprolactone reinforced with an aramid fiber such as the shortlength aramid fiber sold by Dupont under the brand name Kevlar®. Incertain embodiments, using polycaprolacton combined with Kevlar® mayallow moldable tray 730 to soften at low temperatures and set hard attemperatures of approximately 60 degrees Celsius. In certainembodiments, using polycaprolacton combined with Kevlar® may improve thehardness of moldable tray 730 following the molding process, which mayimprove the ability of moldable tray 730 to hold its shape when beingused to adjust the user's jaw position and/or hold a mask or otherbreathing device in place. In certain embodiments, this increasedhardness may also improve the ability of moldable tray 730 to hold itsshape for longer periods of time. For example, in certain embodiments,this may allow moldable tray 730 to substantially hold its shape forperiods longer than approximately 1 month, though such period is notrequired. Using polycaprolacton combined with Kevlar® may also allow forthinner embodiments of moldable tray 730, which may allow moldable tray730 to take up less space in the user's mouth. Examples ofpolycaprolactone combined with an aramid fiber, including Kevlar® and avariety of other fibers, are described in U.S. application Ser. No.11/368,991, publication number U.S. 2007/0004993 A1, which isincorporated herein by reference. Such embodiments may provide animproved moldable material that better maintains its form when heated,providing increased viscosity which may prevent the material fromflowing excessively around the user's teeth and/or getting stuck on theuser's teeth during the molding process. Such embodiments may alsopossess increased strength after molding. In certain embodiments, thethermoplastic material may be cross-linked by radiation, which maycreate cross-linking of certain molecules to improve the material'sshape retention characteristics and/or make the material better able toreturn to its original shape after reheating. In certain embodiments,radiation may be applied after moldable tray 730 has been overmoldedwith arched frame 700, but before being molded to the user, though thisis not required. Cross-linking by radiation is further described in U.S.Pat. No. 5,415,623, which is incorporated herein by reference. Incertain embodiments, the material may exhibit slight shrinkage afterbeing molded to the user's dental arch. In particular embodiments, suchshrinkage may be less than 1%. Slight shrinkage of the materialfollowing the molding process may allow for improved fit with the user'sdental arch. In some embodiments, slight shrinkage of the materialfollowing the molding process may allow moldable tray 730 to have a“snap” fit with the user's dental arch.

In some embodiments, arched frame 700 may be primarily composed of asubstantially rigid material, such as Nylon or any other materialproviding substantial rigidity while allowing moderate flexion. Incertain embodiments, arched frame 700 may be composed of a materialwhose form does not substantially changed when heated to the temperaturerequired to soften the moldable material of moldable tray 730. Forexample, in some embodiments, arched frame 700 may be composed of amaterial that substaintially maintains its shape when heated up to atleast 100 degrees Celsius. Such materials may include polycarbonate,Nylon, acrylonitrile butadiene styrene (ABS), or polyethylene. Incertain embodiments, arched frame 700 may be composed of a semi-flexiblematerial, for example liquid silicone rubber (LSR), approximately havinga Shore 30-90 hardness, although this particular hardness is notrequired.

FIGS. 10A through 10C illustrate an example moldable tray 730substantially surrounding an example arched frame 700. As shown in FIG.10A, example moldable tray 730 may include occlusal surface 732, outerrim 734, and inner rim 736; and arched frame 700 may include occlusalsurface 702 and flange 706. As shown in FIG. 10A, in certain embodimentsthe labial edge of outer rim 734 may extend outward beyond the labialedge of flange 706. The lingual edge of inner rim 736 may also extendinward beyond the labial edge of occlusal surface 702. As seen in FIG.10B, in certain embodiments the distal end of moldable tray 730 mayextend distally beyond the distal end of arched frame 700. In certainembodiments, the distal end of arched frame 700 may extend approximatelyto the user's first molar, while the distal end of moldable tray 730extends approximately to the user's second or third molar. Inalternative embodiments, the distal end of arched frame 700 may extendapproximately to the user's second molar, while the distal end ofmoldable tray 730 extends approximately to the user's third molar. Instill other embodiments, the distal ends of arched frame 700 andmoldable tray 730 may be approximately coextensive.

In certain embodiments, when moldable tray 730 is oriented for placementon, for example, a user's maxillary arch, the superior surface of outerrim 734 may extend beyond the superior surface of flange 706 byapproximately 2.5 millimeters while the inferior surface of moldabletray 730 may extend below the inferior surface of arched frame 700 byapproximately 1.5 millimeters, although these dimensions are notrequired. In certain embodiments, moldable tray 730 may extend outwardbeyond the labial edge of arched frame 700 by approximately 1.5millimeters, though other dimensions are possible. In certainembodiments, moldable tray 730 may extend inward beyond the lingual edgeof arched frame 700 by approximately 1.5 millimeters, though otherdimensions are possible.

In certain embodiments, flange 706 may help maintain the shape of outerrim 734. Moldable trays that substantially surround an arched frame mayallow for reduced bulk between a user's incisors when the tray(s) areinserted into the user's mouth. By providing moldable trays with lessmaterial between the user's incisors, certain embodiments may allowusers to close their mouths further with the trays inserted, which mayimprove comfort and/or effectiveness. Furthermore, moldable trays thatsubstantially surround arched frame may allow for mouth pieces whereonly the moldable material touches the inner surfaces of the user'smouth, such as the user's gums, lips, and tongue. Such moldable traysmay also allow for improved molding to the user's front teeth. Havingarched frame 700 substantially surrounded by moldable tray 730 may alsoreduce the chances of damage to arched frame 700 and may help hold anybroken pieces of arched frame 700 in place, preventing any such brokenpieces from contacting the user's mouth or entering the user's airway.

In certain embodiments, arched frame 700 may include apertures inocclusal surface 702 and/or flange 706, though such apertures are notrequired. Such apertures may allow the moldable material to flow througharched frame 700 during the molding process, which may provide greaterstiffness following the molding process and may allow for improvedalignment of arched frame 700 with moldable tray 730.

FIG. 11A illustrates another example moldable tray 730 having occlusalsurface 732, outer rim 734, inner rim 736, and notches 742. In thisembodiment, moldable tray 730 is attached to a post 802 having slot 804,channels 806, and tension element channel 834. FIG. 11B also illustratesa lower isometric view of the same embodiment showing outer rim 734,notch 742, and a lower surface 744. As shown in FIG. 11A, in certainembodiments moldable tray 730 may be custom molded to fit a particularuser's dental arch. In particular embodiments moldable tray 730 mayinclude one or more notches 742 which may facilitate grasping themoldable tray for improved insertion into and removal from the user'smouth. As shown in FIG. 11B, in certain embodiments lower surface 744 ofthe moldable tray 730 may also be molded to fit the user's second dentalarch. In certain embodiments, molding lower surface 744 to the user'smandibular dental arch may be performed with the user's mandibulardental arch placed in a particular position relative to the user'smaxillary dental arch. For example, the user's mandibular dental archmay be extended in the anterior direction, which may help open a user'sairway allowing for improved breathing. Molding lower surface 744 to theuser's mandibular dental arch may also help hold the user's jaw in adesired position, such as, for example, when upward force is applied tothe user's mandible by a chin strap or other device.

In certain embodiments, a second moldlable tray configured to engagewith the user's second dental arch may be fused with moldable tray 730,locating the user's mandibular arch in a particular position relative tothe user's maxillary arch. In such embodiments, the second moldable traymay be fused to moldable tray 730 prior to forming a mold of the user'sdentition. In alternative embodiments, the second moldable tray may forma separate piece prior to being molded to the user's dentition. In suchembodiments, the second moldable tray and moldable tray 730 may beheated and fused together during the molding process.

Alternative embodiments may utilize a custom-made tray rather than amoldable tray. In some embodiments, a custom-made tray may be pre-fittedand then molded from a substantially rigid material, such as, forexample, acrylic. Certain embodiments may have two separate custom-madetrays coupled together via an adjustment mechanism, such as, forexample, those described in U.S. Pat. No. 7,748,386, which isincorporated herein by reference. In certain embodiments, such anadjustment mechanism may have wedges in the side that interact to movethe user's lower jaw forward.

FIG. 12 illustrates two moldable trays 730, a mask 850, and a coupler800. FIG. 13 illustrates a side view of the components shown in FIG. 12.As shown, moldable trays 730 include occlusal surface 732, outer rim734, and inner rim 736. Mask 850 is a device for directing the flow ofair and/or other gases to a user. Coupler 800 adjustably couples mask850 to at least one moldable tray 730. In the embodiment shown, twomoldable trays 730 cooperate to form an adjustable oral applianceconfigured to adjustably position the lower arch of a user relative tothe user's upper arch. As shown, upper moldable tray 730, includes post802 that extends anterior to the user's mouth when upper moldable tray730 is positioned proximate to the user's maxillary dentition.Similarly, lower moldable tray 730 includes tension element 830 thatextends anterior to the user's mouth when lower moldable tray 730 ispositioned proximate to the user's mandibular dentition. In thisembodiment, post 802 includes a tension element channel 834 to receivetension element 830. In certain embodiments, tension element 830 may bethreaded and may be coupled to adjustment knob 832, which may be turnedto adjust the position of lower moldable tray 730 relative to uppermoldable tray 730. Although tension element 830 is described as beingthreaded, other configurations may be used to adjust the relativepositions of upper and lower moldable trays 730. In alternativeembodiments, tension element 830 may attach to an adjustable oralappliance, such as the oral appliance described in U.S. Pat. No.7,748,386. In certain embodiments, upper moldable tray 730 and lowermoldable tray 730 may be used with or without a mask. In theseembodiments, moldable trays 730 may function as an oral appliance onlyor may be used during surgery or post-surgery to maintain the user'sairway during the administering of anaesthetics or during ventilation,or they may be in place in the event that resuscitation becomesnecessary.

Mask 850 includes one or more flanges 822, with each flange 822including a slot 824. Flange 822 may be fixed to or integrally formedwith mask 850; or flange 822 may be removably coupled to mask 850.However, it should be appreciated that flange 822 may be fixed to orintegrally formed with other mask types, or flange 822 may be removablycoupled to and/or interchangeable with other mask types. In embodimentsin which a single flange 822 is used, flange 822 may have a thickness ofbetween 10-22 millimeters, though such dimensions are not required. Inother embodiments, flange 822 may have a thickness of between 12-18millimeters. In a particular embodiment, flange 822 may have a thicknessof approximately 14 millimeters. In embodiments having multiple flanges822, each flange 822 may have a thickness of between 1-4 millimeters,though this range is not required. In a particular embodiment having amultiple flanges 822, one or more of the flanges 822 may have athickness of approximately 3 millimeters. In certain embodiments havingmultiple flanges 822, when the mask is oriented to the user's face, thedistance between the right edge of the rightmost flange 822 and the leftedge of the leftmost flange 822 may be similar to the ranges describedabove for a single flange 822. For example, in a particular embodimenthaving two flanges 822, the span between the inner edges of the flangesmay be approximately 6 millimeters and the span between the outer edgesof the flanges may be approximately 14 millimeters, though otherdimensions may be used. Such embodiments may improve the ability ofcoupler 800 to prevent deformation outside of the sagittal plane.

As shown in FIG. 12, mask 850 is a pillow mask with nasal inserts 852that may be configured to seal against the user's nostrils. In certainembodiments, nasal inserts 852 may be fitted independently to mask 850and may be capable of rotating independently to the angle of the user'snostrils. In certain embodiments, nasal inserts 852 may be removeablycoupled to mask 850 and may be interchangeable with different sizes ofnasal inserts 852. In some embodiments, the user may select differentsizes of nasal inserts 852 for each nostril. In alternative embodiments,nasal inserts 852 may be formed together as a pair and attached as oneunit to mask 850. In other embodiments, nasal inserts 852 may be fixedpermanently to mask 850. In certain embodiments, mask 850 may have aninlet that is fixed on the top of the frame for delivering air and/orother gases to mask 850. In some embodiments, mask 850 may have a balljoint, elbow, or a combination thereof delivering air and/or other gasesto mask 850. In alternative embodiments, air and/or other gases may bedelivered in the side or the bottom of mask 850. In certain embodiments,air and/or other gases may be delivered through several different tubes.In certain embodiments, the user may be able to select one or moreconnection points for delivery of air and/or other gases and plug orotherwise disable other connection points. In other embodiments, a mainhose may attach directly to mask 850 or to an elbow joint or a balljoint. In certain embodiments, mask 850 may have a length of flexibletubing that may connect with a main hose. In certain embodiments, theoptional flexible tubing may be approximately 50-300 millimeters long,though this is not required. In one example embodiment, mask 850 mayhave a 250 millimeter-long flexible tube. In certain embodiments, suchtubing may be light, flexible, and have a smaller diameter than the mainhose. In some embodiments, the flexible tubing may have a diameter ofapproximately 12-19 millimeters, while the main hose may have a diameterof approximately 22 millimeters, though these dimensions are notrequired. In one example embodiment, the flexible tubing may have aninternal diameter of approximately 17 millimeters. In certainembodiments, there may be a connector between the short flexible tubeand the main tube, and in some embodiments this connector may be capableof swivelling. In particular embodiments, the connector may be a balljoint or a straight connector. In certain embodiments, optional headgearmay be supplied that attaches to mask 850, coupler 800, and/or moldabletray 730. Such headgear may pass along the side of the user's face andmay be capable of holding the main hose or other air-delivery device ina particular position. For example, in certain embodiments, suchheadgear may hold the main hose in place on top of the user's head or toone or both sides of the user's head. In certain embodiments, suchheadgear may also be configured to help hold moldable tray 730, or anyother oral appliance, in the user's mouth. In some embodiments, suchheadgear may be adjustable at a connection point on mask 850 and/or atone or more places around the user's head. In alternative embodiments,the headgear may be formed from a stretchable material and may requirelittle or no manual adjustment. In one example embodiment, the headgearmay be at least partially made from Breath-o-prene®, which is a soft,breathable laminate. In another example embodiment, the headgear may beat least partially made from silicone or a molded thermoplastic/fabriccomposite. In other embodiments, the headgear may be formed from acombination of these materials, or from a combination of these and othermaterials. In certain embodiments, a chin strap may attach to mask 850,headgear, or moldable tray 730 or any other oral appliance. In someembodiments, mask 850 may have bias flow (vent holes) to flush out theuser's exhaled breath. In such embodiments, mask 850 may have aplurality of holes to enable bias flow. In certain embodiments, mask 850may have approximately 10-50 holes, though this is not required. In oneexample embodiment, mask 850 may have approximately 35 holes. In theseembodiments, the holes may be approximately 0.75 millimeters indiameter, though these dimensions are not required. In certainembodiments, the holes may have non-uniform cross-sectional shapesthroughout the length of the holes. In one example embodiment, one ormore of the holes may be rounded and have an opening diameter ofapproximately 1.2 millimeters, the diameter of the hole falling toapproximately 0.75 millimeters when moving through the hole and thenexpanding again to a diameter greater than 0.75 millimeters when movingthrough to the other end of the hole. In alternative embodiments, theholes may be tapered from one side or the other, or the holes may bestraight throughout. In certain embodiments, having many small holes mayslow the flow of gas and may reduce the draft and noise of such flow. Inother embodiments, mask 850 may have no holes, which may enableclosed-loop ventilation. In certain embodiments, mask 850 may be firstformed in two or more distinct pieces and then joined, for example, bywelding, gluing, clipping, screwing, latching, strapping, or otherwisefixing the pieces together. In other embodiments, the mask may initiallybe formed as a single piece. Furthermore, those skilled in the art willappreciate that the headgear, tubes, bias holes, chin straps,attachments, assembly features, and other aspects described above mayalso apply to other masks described herein.

Post 802 may include one or more channels 806 and a slot 804. In theembodiment shown, coupler 800 is formed by two flanges 822 engaging twochannels 806. The movement of flanges 822 relative to channels 806 islimited by fastener 805 in slot 804. Fastener 805 may represent anystructure that can restrict the movement of flanges 822 relative tochannels 806. In certain embodiments, fastener 805 may be a pin, screw,or bolt. In the embodiment shown, fastener 805 is a threaded hex-headbolt that engages a hex-head counter sink 807 on one side of post 802and a tightening knob 808 on the other side of post 802. In certainembodiments, a hex-head (or other appropriately shaped) countersink mayprevent rotation of fastener 805 while tightening knob 808 or otherappropriate structure is fixing the position of fastener 805. In aparticular embodiment, both sides of post 802 may include a countersink,such that a user may select to position tightening knob 808 on eitherside of post 802. This flexibility may make the use of tightening knob808 equally convenient to left-handed and right-handed users. Inalternative embodiments, post 802 may include an additional tighteningknob opposite tightening knob 808, enabling adjustment from either sideof post 802.

FIG. 14A illustrates the anterior end of an example post 802 and FIG.14B illustrates an example anterior view of an example arched frame 700with a tension element 830. As shown in FIG. 14B, in certain embodimentsat least a portion of the tension element may be threaded, and thethreaded portion may engage with the tension element adjustor 832. Inthe embodiments shown, post 802 includes D-shaped slot 834 and tensionelement 830 has a corresponding D-shaped cross-section. In certainembodiments, the D-shaped slot 834 and tension element 830 maysubstantially prevent tension element 830 from rotating when adjustmentknob 832 is used to adjust tension element 830. Although a D-shape isillustrated, other cross-sections may be used to prevent the rotation oftension element 830 in slot 834. As one example, slot 834 may have a“key” structure that corresponds with a channel in tension element 830.

FIGS. 15A and 15B illustrate example flanges 822. As shown in FIG. 15A,flange 822 may include a slot 824. While FIG. 15B depicts two distinctflanges 822, alternative embodiments may have a single flange, multipleflanges, or any other structure which may be secured in place relativeto post 802 by fastener 805. In alternative embodiments, slot 824 mayhave various shapes, sizes, and orientations. In certain embodiments,flanges 822 may be formed and/or molded as one part. In otherembodiments, flanges 822 may be formed from multiple parts that may beassembled, clipped, screwed, or overmolded. In various embodiments,flanges 822 may consist of plastic and/or metal such as stainless steel.

FIGS. 16A and 16B illustrate an example post 802 having a fastener 805,channels 806, countersink 807, tightening knob 808, and a tensionelement channel 834. As shown in FIG. 16A, an end of fastener 805 may beconfigured to engage with countersink 807. In certain embodiments, asshown in FIG. 16B, at least a portion of fastener 805 may be threaded.As shown in FIG. 16B, in some embodiments slot 804 (not shown) may crosslaterally through post 802, allowing fastener 805 to pass laterallythrough post 802 across channels 806. In some embodiments, when flanges822 are disposed in channel 806, slots 824 may substantially align withslot 804, allowing fastener 805 to pass through both slot 804 and slots824. In such an embodiment, tightening knob 808 may be adjusted toincrease or decrease lateral force exerted along the long axis offastener 808. Adjusting tightening knob 808 in such an embodiment mayoperate to secure flanges 822 in place relative to post 802. In certainembodiments, an attached mask or breathing device may be moved into thedesired position relative to the user's face and then fixed into thatposition by adjusting tightening knob 808.

In certain embodiments, post 802 may be formed and/or molded as onepart. In other embodiments, post 802 may be formed from multiple partsthat may be assembled, clipped, screwed, or overmolded. In variousembodiments, post 802 may consist of plastic and/or metal such asstainless steel.

FIGS. 17A through 17F illustrate various positions of an example coupler800. As shown in FIG. 17A, coupler 800 may include a flange 822 withslot 824 and a post 802 having a fastener 805 and countersink 807. Asshown in FIGS. 17A through 17F, in certain embodiments, flange 822 maybe capable of moving in the superior-inferior direction relative to post802, moving in the anterior-posterior direction relative to post 802,and rotating around fastener 805. In alternative embodiments, flange 822may be capable of moving in the superior-inferior direction relative topost 802 and rotating around fastener 805. In certain embodiments,flange 822 may be limited to adjustment, rotation, and/or movementwithin the sagittal plane. In some embodiments, post 802 may include anadditional joint that may provide adjustment, rotation, and/or movementin one or more additional directions. In certain embodiments, flange 822may be adjusted vertically approximately +/−10 mm, though other rangesmay be used. For example, other embodiments may have vertical adjustmentranges of between +/−7 mm and +/−14 mm. In certain embodiments, flange822 may be adjusted in the anterior-posterior direction approximately+/−5 mm, though other ranges may be used. For example, other embodimentsmay have horizontal adjustment ranges of between +/−3 mm and +/−8 mm. Incertain embodiments, when flange 822 has a desired position andorientation, tightening knob 808 may be adjusted to secure flange 822 inplace relative to post 802.

FIG. 18 illustrates another example post 882 having a fastener 805,plates 884, channels 806, tightening knob 808, and plate 886. Inparticular embodiments, plates 884 may define channels 806, which areconfigured to receive flanges 822. As shown in FIG. 18, post 882 may becylindrical and hollow. In a particular embodiment, post 882 may consistof metal, such as stainless steal. In alternative embodiments, post 882may have various structures, shapes, and densities and can be made froma wide variety of rigid materials. In some embodiments, plate 886 may beattached at the posterior end of post 882. Plate 886 may be configuredto couple to the front of an oral appliance such as those described, forexample, in U.S. Pat. No. 7,748,386, which is incorporated herein byreference.

FIG. 19A illustrates an example mask 890 having flanges 822 with slots824 and a hose coupler 854 coupled to a hose 870. FIG. 19B illustrates aside view of mask 890, showing opening 856 and flanges 822. In certainembodiments, as shown in FIG. 19B, flanges 822 may be fixed to orintegrally formed with mask 890. In alternative embodiments, flanges 822may be removably coupled to the anterior surface of mask 890. In someembodiments, opening 856 may allow structures, such as post 802 or post882, to pass through the front of mask 890 and couple with flanges 824.In certain embodiments, opening 856 may be sized to accommodate variouspositions and orientations of post 802 relative to mask 890.

FIG. 20 illustrates an example mask 892 coupled to an example post 802.As shown, mask 892 includes a seal 860, opening 856, flanges 822, and ahose coupler 854. As shown, post 802 is attached to moldable tray 730inside the user's mouth, allowing mask 892 to be adjustably oriented tothe user's face. In certain embodiments, mask 892 may be adjustedvertically, adjusted in the anterior-posterior direction, and/or rotatedin the sagittal plane. In certain embodiments, as shown in FIG. 20, seal860 may include flexible gasket 862 which may be configured to allowpost 802 to pass through it and couple with flanges 824, forming anair-tight seal around post 802. Flexible gasket 862 may also allow mask892 to be adjusted to various positions and orientations relative to theuser's face without significantly disturbing post 802 or breaking theairtight seal of seal 860. In some embodiments, as shown in FIG. 20,flexible gasket 862 may incorporate or be surrounded by creases, whichmay improve the ability of flexible gasket 862 to accommodate variouspositions of post 802, though such creases are not required. In certainembodiments, post 802, or another suitable post such as post 882, mayattach to various oral appliances, allowing for various combinations oforal appliances, posts, and masks. In alternative embodiments, flanges822 may be contained within a mask, providing the substantially similarmovement and adjustment to mask 892. In such embodiments, fastener 805may pass through a gasket in the mask's seal to a position outside themask where it could be operated by a user.

Having mask 892 secured to the user's oral appliance may obviate theneed for the user to wear stabilizing headgear. Such straps may shiftaccidentally, may be uncomfortable for the user, may leave marks on theuser's face, and may irritate the user's face and scalp. Furthermore,since having mask 892 secured to the user's oral appliance may preventsubstantial movement of mask 892 relative to the user's face and preventleakage, these embodiments may reduce the need to tighten the mask tothe user's face, which may result in reduced pressure on the user's faceand reduced pressure sores. These embodiments may also provide greatermask stability during sleep for users who exhibit substantial movementduring sleep. It should be appreciated that all such embodiments andadvantages described with respect to mask 892 may also apply to othermask described herein, such as, for example, masks 850 and/or 894.

In alternative embodiments, mask 892 may be held in place by a tensionelement attached to an oral appliance, with the tension element pullingmask 892 toward the oral appliance and the user's face. In certainembodiments, the pull of the tension element may be adjusted by a screw,tightening knob, or other adjustment mechanism. Following adjustment, incertain embodiments mask 892 may be secured via a fastener, such as ahook.

While FIG. 20 shows mask 892 as a full face mask covering the user'snose and mouth, FIGS. 21A and 21B illustrate an alternative mask 894covering the user's mouth and delivering air and/or other gases to theuser's nose via nasal inserts 852. In certain embodiments, as shown inFIG. 21B, seal 860 may extend below the user's chin. Masks with portionsthat extend below a user's chin may improve the function of the mask bypreventing and/or reducing the occurrence of the user opening theirmouth while using the mask. Still other embodiments incorporatingdifferent types of masks will be apparent to those skilled in the art.In certain embodiments, when flanges 822 of mask 894 are disposed inchannels 806 of post 802, movement of mask 894 outside of the sagittalplane is strongly resisted, which may help prevent mask leakage if auser lays on his or her side, pushing mask 894 laterally against asurface such as a pillow.

Various types of masks may be used in other embodiments. For example,certain embodiments may use pillow masks, which seal against the user'snostrils; nasal masks, which cover the user's nose; full face masks,which cover both the user's mouth and nose; hybrid masks, which have oneportion covering a user's mouth and another portion covering the user'snose or sealing against the user's nostrils; or oral masks, which coverthe user's mouth. Such masks may be used for the delivery of pressurizedair, oxygen, aerosols, gasses, or medication; and the masks may bevented or non-vented. Masks included in various embodiments may be usedfor continuous positive airway pressure treatment (CPAP), auto-CPAP, orbilevel or closed-loop ventilation; and masks may be custom-fitted to aparticular user or they may be non-custom masks that conform todifferent face shapes.

In certain embodiments, a venting seal may be combined with the masksand/or oral appliances disclosed herein. In certain embodiments, theventing seal may be fixed or detachable. The venting seal may bepositioned outside the user's mouth next to the user's lips or theventing seal may be positioned behind the user's lips next to the user'steeth. In certain embodiments, the venting seal may reduce or eliminatethe venting of air or other gases from the user's mouth, such as forexample when air or other gases are being supplied to the user's nose.An example venting seal is disclosed in U.S. Pat. No. 6,675,802,incorporated herein by reference. In certain embodiments, the ventingseal may be attached to post 802, post 882, or other appropriatestructure, either removably or permanently.

FIGS. 22A and 22B and FIG. 23 illustrate an example mask 900 having ahose coupler 902 and a strap 904 with a plurality of apertures 906. Asshown in FIG. 22A, hose coupler 902 may be configured to attach to ahose 910 which may deliver air and/or other gases to mask 900. Incertain embodiments, as shown in FIG. 23A, strap 904 may span theopening of hose coupler 902. As shown in FIG. 23A, strap 904 may have aplurality of apertures along its length. In certain embodiments, asshown in FIG. 22B, a tension element 920 may pass through one of theplurality of apertures 906 and attach to oral appliance 930, which maybe any mouthpiece configured to couple to tension element 920. FIG. 24illustrates an example oral appliance 930, mask 900, and tension element920. As shown in FIG. 24, tension element 920 has a threaded knob 924and a hook 922. Oral appliance 930 includes a receiver to engage tensionelement 920 to pull mask 900 towards oral appliance 930. In certainembodiments, the receiver in oral appliance 930 may be a loop, a latch,or a slot. In a particular embodiment, tension element 920 includes hook922 and threaded knob 924. In alternative embodiments, tension element920 may include one or more alternative structures to pull mask 900towards oral appliance 930.

FIGS. 25A and 25B illustrate an example mask 950 and adapter 960. Asshown in FIGS. 26A and 26B, in certain embodiments adapter 960 mayinclude a hose coupler 962, a strap 904 having a plurality of apertures906, and a mask coupler 968. In some embodiments, hose coupler 902 maybe configured to couple with a hose 910. As shown in FIGS. 25A and 25B,mask coupler 968 may be configured to couple with hose coupler 952 ofmask 950, allowing adapter 960 to couple with mask 950. When adapter 960is coupled to mask 950, adapter 960 may allow mask 950 to interact withhose 910 and tension element 920 as described in the above descriptionof mask 900.

FIG. 27 illustrates an example dental device comprising a universalcoupler and an example dental attachment. As shown in FIG. 27, a dentaldevice is provided comprising an arched frame 100, a moldable tray 135,a second arched frame 200, and a second moldable tray 235. Arched frame100 may comprise a universal coupler comprising a substantially planarsurface 145. In particular embodiments, a hook 405 may be configured toengage the universal coupler. In particular embodiments, second archedframe 200 may comprise a receiving mechanism 130 coupled to the lingualportion of second arched frame 200. Receiving mechanism 130 may be a barthat spans the lingual portion of second arched frame 200. In particularembodiments, hook 405 may engage receiving mechanism 130 to adjust theforward position of arched frame 100 relative to second arched frame200. In certain embodiments, this adjustment may help to prevent a userfrom snoring when the dental device is inserted in the user's mouth.

FIG. 28 illustrates an example dental device comprising a universalcoupler and an example dental attachment. As shown in FIG. 28, a dentaldevice is provided comprising an arched frame 100, a moldable tray 135,a second arched frame 200, and a second moldable tray 235. Arched frame100 may comprise a universal coupler comprising a substantially planarsurface 145. In particular embodiments, a substantially roundedprojection 415 may be configured to engage the universal coupler. Inparticular embodiments, rounded projection 415 may be the only point ofcontact between the user's upper and lower dental arches to prevent auser from clenching his jaw when the dental device is inserted in theuser's mouth. In particular embodiments, rounded projection 415 maycontact an opposing arch or may contact one or more incisors of theopposing dental arch to prevent a user from clenching his jaw when thedental device is inserted in the user's mouth. The opposing arch mayhave a contact surface that may be planar.

The universal oral appliance comprising a universal coupler may provideseveral advantages for a user. In particular embodiments, a universaloral appliance comprising a universal coupler may offer more use optionsto a user. For example, a user's appliance may be fitted with severaldifferent dental attachment options. The user may choose which dentalattachment is best suited for his situation without having to hire a labto construct another appliance. In particular embodiments, a particularuser may also adjust the dental attachment to better suit the shape andsize of the user's mouth. This disclosure contemplates the universaloral appliance being created from parts in a kit. A user may purchasethe kit instead of a dental device created in a laboratory.

FIG. 29 illustrates an example arch comprising a dental attachment. Asshown in FIG. 29, an arch is provided that comprises an arched frame 100and a moldable tray 135 coupled to arched frame 100. Arched frame 100comprises an arched body 105 that defines a plurality of apertures 110.The arch may further comprise a dental attachment configured to engagearched frame 100. In particular embodiments, the dental attachment isconfigured to engage arched frame 100 along the midline of arched frame100. In particular embodiments, the dental attachment may comprise apost 500 and an anchoring element 505. Post 500 may be coupled at afirst end to anchoring element 505. In particular embodiments, a secondend of post 500 may engage arched frame 100. In some embodiments, post500 may be configured to removably engage arched frame 100. Inparticular embodiments, anchoring element 505 may include a buckle, aslot, a clasp, a clamp, and/or any other appropriate element to anchor atension element. In some embodiments, anchoring element 505 may beconfigured to be outside a user's mouth when the arch is inserted in theuser's mouth. In some embodiments, the dental attachment may furthercomprise a release mechanism 510. As an example and not by way oflimitation, release mechanism 510 may be a button or a latch. Althoughthis disclosure describes certain types of release mechanisms 510, thisdisclosure contemplates any suitable release mechanism 510. Althoughthis disclosure describes an arch comprising arched frame 100, moldabletray 135, and a dental attachment, this disclosure contemplates aone-piece arch comprising a dental attachment.

FIG. 30 illustrates an example arch comprising a second anchoringelement and a tension element. As shown in FIG. 30, an arch is providedthat comprises an arched frame 200 and a moldable tray 235 coupled toarched frame 200. Arched frame 200 comprises an arched body 205 thatdefines a plurality of apertures 210. The arch may further comprise asecond anchoring element 245. In particular embodiments, secondanchoring element 245 may be coupled to the arch along the midline ofthe arch. The arch may further comprise a tension element 515. Inparticular embodiments, tension element 515 may be flexible and may beconfigured to engage second anchoring element 245. In particularembodiments, tension element 515 may be further configured to couple toan anchoring element outside a user's mouth when the arch is inserted inthe user's mouth. In some embodiments, tension element 515 may comprisea strap 520 and a coupler 516. Coupler 516 may be configured to engagethe second anchoring element. In particular embodiments, coupler 516 maybe configured to removably engage the second anchoring element. Strap520 may be coupled to coupler 516. In particular embodiments, strap 520may be configured to engage the anchoring element outside the user'smouth when the arch is inserted in the user's mouth. In particularembodiments, strap 520 may comprise a hard plastic, leather, or metal.In certain embodiments, strap 520 may be a zip tie. In otherembodiments, strap 520 may be a wire, belt, string, or any otherappropriate element to engage the anchoring element. Although thisdisclosure describes an arch comprising arched frame 200, moldable tray235, and tension element 515, this disclosure contemplates a one-piecearch comprising tension element 515.

FIG. 31 illustrates an example dental device comprising a dentalattachment, a second anchoring element, and a tension element. As shownin FIG. 31, a dental device is provided that comprises an arched frame100 and a second arched frame 200. The dental device further comprises amoldable tray 135 coupled to arched frame 100 and a second moldable tray235 coupled to second arched frame 200. The dental device may furthercomprise a dental attachment configured to engage arched frame 100. Inparticular embodiments, the dental attachment may comprise a post 500and an anchoring element 505. The dental device may further comprise asecond anchoring element 245. Second anchoring element 245 may becoupled to second arched frame 200. The dental device may furthercomprise a tension element 515. Tension element 515 may be configured toengage second anchoring element 245. In particular embodiments, tensionelement 515 may comprise a coupler 516 and a strap 520. In particularembodiments, strap 520 may be configured to engage anchoring element 505outside the user's mouth when the dental device is inserted in theuser's mouth. Anchoring element 505 may be configured to securesubstantially the length of strap 520 engaged to anchoring element 505.In particular embodiments, increasing the length of strap 520 engaged toanchoring element 505 will adjust the forward position of arched frame100 relative to second arched frame 200. In particular embodiments, thedental attachment may further comprise a release mechanism 510.

FIG. 32 illustrates an example dental attachment and tension element. Asshown in FIG. 32, a dental attachment is provided comprising a post 500and an anchoring element 505. Anchoring element 505 may be coupled to anend of post 500. A tension element is also provided comprising a strap520. Strap 520 may be configured to engage anchoring element 505.Anchoring element 505 may be configured to secure the length of strap520 engaged to anchoring element 505. In particular embodiments, thedental attachment may comprise a release mechanism 510. Releasemechanism 510 may be configured to release strap 520 from anchoringelement 505.

FIG. 33 illustrates an example dental device in a user's mouth. As shownin FIG. 33, a dental device is provided that comprises an arched frame100, a second arched frame 200, a moldable tray 135 coupled to archedframe 100, and a second moldable tray 235 coupled to second arched frame200. Moldable tray 135 may comprise a channel 140 configured to engageat least some of the teeth of the user's maxillary arch 305. Secondarched frame may comprise a second arched body 205 that defines a secondplurality of apertures 210. The dental device may further comprise adental attachment. The dental attachment may comprise a post 500 and ananchoring element 505. Anchoring element 505 may be coupled to an end ofpost 500, and a second end of post 500 may be configured to engagearched frame 100. Anchoring element 505 may be configured to be outsidethe user's mouth when the dental device is inserted in the user's mouth.The dental device may further comprise a second anchoring element 245coupled to second arched frame 200. The dental device may furthercomprise a tension element comprising a coupler 516 and a strap 520.Coupler 516 may be configured to engage second anchoring element 245.Strap 520 may be coupled to coupler 516 and may be configured to engageanchoring element 520 outside the user's mouth when the dental device isinserted in the user's mouth. Anchoring element 505 may be configured tosecure substantially the length of strap 520 engaged to anchoringelement 505. In particular embodiments, increasing the length of strap520 engaged to anchoring element 505 may adjust the forward position ofarched frame 100 relative to second arched frame 200. In particularembodiments, adjusting the forward position of arched frame 100 relativeto second arched frame 200 may adjust the forward position of the user'smaxillary arch 305 relative to the user's mandibular arch 300. Inparticular embodiments, adjusting the forward position of the user'smaxillary arch 305 relative to the position of the user's mandibulararch 300 may help to improve the user's breathing and/or prevent theuser from snoring.

In particular embodiments, the dental device comprising a dentalattachment and a tension element may allow a third party faster accessto a user's mouth and airway. For example, if the user is a patientsleeping in a sleep laboratory, a doctor in the laboratory may quicklypull on the tension element to open an airway that closed while thepatient slept. As another example, if the user is a patient undergoingsurgery in a hospital, a surgeon may quickly release the tension elementto open the patient's mouth for intubation or for insertion of aninstrument while the patient is sedated. In particular embodiments, thedental device comprising a dental attachment and a tension element maypull the user's lower jaw forward without locking the lower jaw inplace. The user's lower jaw will maintain a certain range of lateralmotion while the dental device is inserted in the user's mouth. Thisdisclosure contemplates the dental device comprising a dental attachmentand a tension element being created from a kit. A patient, doctor, orsurgeon may purchase the kit and create the dental device quickly. Inparticular embodiments, the dental device may be a disposable devicethat may be thrown out after one or more uses.

FIG. 34 illustrates an example process for creating a dental device. Atstep 600, an arched frame is formed. In particular embodiments, thearched frame may be configured to be positioned proximate to theocclusal surface of a user's dental arch such that the arched frameextends beyond the cuspids of the user's dental arch. The arched framemay define a plurality of apertures. At step 605, an adjustmentmechanism is coupled to the arched frame. In particular embodiments, theadjustment mechanism may comprise a hook and a threaded adjustor. Atstep 610, a moldable tray is formed. In particular embodiments, themoldable tray may comprise a channel configured to engage at least someof the teeth of the user's dental arch. In some embodiments, the channelmay be shaped to conform to the teeth of a generic user's dental arch.In other embodiments, the channel may be a smooth channel configured tocover some of the teeth of the user's dental arch. In particularembodiments, the channel may be further shaped to conform to aparticular user's dental arch. At step 615, the moldable tray is coupledto the arched frame. In particular embodiments, the moldable tray mayengage the plurality of apertures. In particular embodiments the processmay be repeated to form a second arched frame and a second moldabletray. In particular embodiments, the arched frame may comprise kevlarpolycarbon, acrylic, polycarbonate resin thermoplastic, or any othersuitable hard plastic polymer. In particular embodiments, the moldabletray may comprise polycaprolactone.

In particular embodiments, the process illustrated in FIG. 34 may leadto faster creation and production of dental devices. Users may avoidsending dental impressions to a laboratory to create a dental devicesthus saving time and money.

Although example steps are illustrated and described, the presentinvention contemplates two or more steps taking place substantiallysimultaneously or in a different order. For example, step 605, couplingan adjustment mechanism to the arched frame, may be performed after step610, forming a moldable tray. In addition, the present inventioncontemplates using methods with additional steps, fewer steps, ordifferent steps, so long as the steps remain appropriate for creating adental device.

Various embodiments disclosed herein may be used together in a varietyof combinations. For example, in certain embodiments, the various posts,such as posts 802 and 882, may be coupled to any of the various oralappliances disclosed herein, including the oral appliances disclosed inU.S. Pat. No. 7,748,386. As another example, the various posts describedherein may be coupled to any of the various masks disclosed, such as butnot limited to masks 850, 890, 892, and 894. As another example, incertain embodiments, the various adjustment mechanisms may be used withthe various oral appliances disclosed herein, including the adjustmentmechanisms and oral appliances disclosed in U.S. Pat. No. 7,748,386. Asanother example, in certain embodiments the various oral appliances maybe coupled with the various dental attachments disclosed herein.

Although the present invention has been described above in connectionwith several embodiments, changes, substitutions, variations,alterations, transformations, and modifications may be suggested to oneskilled in the art, and it is intended that the present inventionencompass such changes, substitutions, variations, alterations,transformations, and modifications as fall within the spirit and scopeof the appended claims.

What is claimed is:
 1. A method comprising: coupling, to a frame, athermoplastic tray comprising polycaprolactone such that the tray issubstantially between the frame and a dental arch of user when the frameis positioned in the user's mouth, the frame comprising: an occlusalsurface configured to be positioned proximate an occlusal surface of thedental arch of the user, the occlusal surface of the frame comprising: afirst occlusal portion configured to be positioned proximate at leastone of a left bicuspid and a left molar of the dental arch of the user;and a second occlusal portion configured to be positioned proximate atleast one of a right bicuspid and a right molar of the dental arch ofthe user; wherein the occlusal surface of the frame defines a space thatextends between the first occlusal portion and the second occlusalportion, the space configured to be positioned proximate an incisor ofthe dental arch when the frame is positioned in the user's mouth; andirradiating the thermoplastic moldable tray to produce an irradiated,cross-linked thermoplastic polymer that is not customized to any user'steeth and that softens to be moldable to a shape of a portion of theuser's dental arch when the thermoplastic polymer is heated to 40 to 80degrees Celsius.
 2. The method of claim 1, wherein the occlusal surfaceof the frame is configured to be positioned proximate a maxillary dentalarch.
 3. The method of claim 1, wherein the frame comprises a materialthat provides substantial rigidity while allowing moderate flexion. 4.The method of claim 1, wherein the frame comprises a material thatsubstantially maintains its shape at temperatures at or below 100degrees Celsius.
 5. The method of claim 1, wherein the thermoplasticmoldable tray is coupled to the first and second occlusal portions suchthat the frame does not extend beyond the thermoplastic moldable tray ina buccal direction.
 6. The method of claim 1, wherein the thermoplasticmoldable tray extends beyond a labial edge of the frame.
 7. The methodof claim 1 further comprising: heating the thermoplastic moldable trayafter the thermoplastic moldable tray has been irradiated; and moldingthe thermoplastic moldable tray to the user's teeth after thethermoplastic moldable tray has been heated.
 8. A method comprising:coupling, to a frame, a thermoplastic tray comprising polycaprolactonesuch that the tray is substantially between the frame and a dental archof user when the frame is positioned in the user's mouth, the framecomprising: an occlusal surface configured to be positioned proximate anocclusal surface of the dental arch of the user, the occlusal surface ofthe frame comprising: a first occlusal portion configured to bepositioned proximate at least one of a left bicuspid and a left molar ofthe dental arch of the user; and a second occlusal portion configured tobe positioned proximate at least one of a right bicuspid and a rightmolar of the dental arch of the user; wherein the occlusal surface ofthe frame is not contiguous between the first and second occlusalportions, such that the occlusal surface of the frame does not extendproximate at least some incisors of the dental arch of the user; andirradiating the thermoplastic moldable tray to produce an irradiated,cross-linked thermoplastic polymer that is not customized to any user'steeth and that softens to be moldable to a shape of a portion of theuser's dental arch when the thermoplastic polymer is heated to 40 to 80degrees Celsius.
 9. The method of claim 8, wherein the occlusal surfaceof the frame is configured to be positioned proximate a maxillary dentalarch.
 10. The method of claim 8, wherein the frame comprises a materialthat provides substantial rigidity while allowing moderate flexion. 11.The method of claim 8, wherein the frame comprises a material thatsubstantially maintains its shape at temperatures at or below 100degrees Celsius.
 12. The method of claim 8, wherein the thermoplasticmoldable tray is coupled to the first and second occlusal portions suchthat the frame does not extend beyond the thermoplastic moldable tray ina buccal direction.
 13. The method of claim 8, wherein the thermoplasticmoldable tray extends beyond a labial edge of the frame.
 14. The methodof claim 8 further comprising: heating the thermoplastic moldable trayafter the thermoplastic moldable tray has been irradiated; and moldingthe thermoplastic moldable tray to the user's teeth after thethermoplastic moldable tray has been heated.
 15. A method comprising:coupling, to a frame, a thermoplastic tray comprising polycaprolactonesuch that the tray is substantially between the frame and a dental archof user when the frame is positioned in the user's mouth, the framecomprising: an occlusal surface configured to be positioned proximate anocclusal surface of the dental arch of the user, the occlusal surface ofthe frame comprising: a first occlusal portion configured to bepositioned proximate at least one of a left bicuspid and a left molar ofthe dental arch of the user; and a second occlusal portion configured tobe positioned proximate at least one of a right bicuspid and a rightmolar of the dental arch of the user; and irradiating the thermoplasticmoldable tray to produce an irradiated, cross-linked thermoplasticpolymer that is not customized to any user's teeth and that softens tobe moldable to a shape of a portion of the user's dental arch when thethermoplastic polymer is heated to 40 to 80 degrees Celsius.
 16. Themethod of claim 15, wherein the occlusal surface of the frame isconfigured to be positioned proximate a maxillary dental arch.
 17. Themethod of claim 15, wherein the frame comprises a material that providessubstantial rigidity while allowing moderate flexion.
 18. The method ofclaim 15, wherein the frame comprises a material that substantiallymaintains its shape at temperatures at or below 100 degrees Celsius. 19.The method of claim 15, wherein the thermoplastic moldable tray iscoupled to the first and second occlusal portions such that the framedoes not extend beyond the thermoplastic moldable tray in a buccaldirection.
 20. The method of claim 15, wherein the thermoplasticmoldable tray extends beyond a labial edge of the frame.
 21. The methodof claim 15 further comprising: heating the thermoplastic moldable trayafter the thermoplastic moldable tray has been irradiated; and moldingthe thermoplastic moldable tray to the user's teeth after thethermoplastic moldable tray has been heated.